System and method for reduction of inadvertent activation of medical device during manipulation

ABSTRACT

Inadvertent activation of a portable medical device such as an ambulatory infusion pump can be reduced by locking a touchscreen of the device when it is indicated that an uninterrupted operation is to be performed. When a processor receives a device operation input from the touchscreen that indicates an uninterrupted operation is to be performed on the portable device, the touchscreen is automatically locked such that touch input at the touchscreen is not processed by the processor to navigate between or among menu screens or set pump parameters. Following completion of the uninterrupted operation, the touchscreen can be unlocked. In one embodiment, the touchscreen can be unlocked by selection of an unlock icon on the touchscreen.

RELATED APPLICATIONS

This application is a continuation of application Ser. No. 13/801,274filed Mar. 13, 2013, which claims the benefit of U.S. ProvisionalApplication No. 61/637,210 filed Apr. 23, 2012, each of which is fullyincorporated herein in its entirety by reference.

BACKGROUND

Many portable devices include a touchscreen on which symbols aredisplayed and from which inputs are received for operation of theportable device. A series of screens or windows can displayed on thetouchscreen, showing alphanumeric text and symbols and providing menuscreens through which the user can control operation of the portabledevice. User interaction, such as by touching the alphanumeric text andsymbols, provides user input and facilitates navigation through the menuscreens and selection of the device functions. Under some conditions, itis desirable to ignore user interaction with the touchscreen. Forexample, when the portable device is placed in a pocket or a purse,physical contact from objects in the pocket or purse may causeinadvertent device operation to occur. In such conditions, thetouchscreen may be placed in a lock condition. The user is then requiredto perform a particular interaction to resume acceptance of device inputthrough the touchscreen.

One example of a portable device such as described above is a devicethat involves the delivery of fluids. There are many applications inacademic, industrial, and medical fields, as well as others, thatinvolve devices that are capable of accurately and controllablydelivering fluids, including liquids and gases, that have a beneficialeffect when administered in known and controlled quantities. This isparticularly true in the medical field where treatments for manypatients include the administration of a known amount of a substance atpredetermined intervals. The treatment of diabetes involves just such aregimented dosage of medicament such as insulin. In addition, theadministration of insulin for a diabetic patient is one of a few medicalindications in which the patient routinely administers the medicament tothemselves by a subcutaneous modality, such as a hypodermic syringeinjection. As such, providing a patient with the means to safely,reliably, and comfortably administer required doses of medication isparticularly important in order to facilitate patient compliance andaccurate treatment of the condition.

Insulin infusion pumps have been developed for the administration ofinsulin for those diagnosed with both type I and type II diabetes.Insulin pumps are medical infusion devices used for the administrationof insulin in the treatment of diabetes that offer an alternative tomultiple daily injections of insulin by an insulin syringe or an insulinpen. They also allow for continuous insulin therapy.

The functions performed by infusion pumps and similar devices make itespecially important to avoid inadvertent device operation. For example,infusion pumps may be programmed to initiate delivery of fluids atdifferent times of a day, but such delivery would be annoying or evendangerous if a user happens to be involved in replacing a cartridge orchanging a tube at the time of the programmed delivery time. Such loadsequences of operation should not be interrupted until completion.Relatively simple display lock protections may not be adequate toprotect against programmed device operation when a user is engaging inan activity that should not be interrupted.

Accordingly, there is a need for a portable medical device that safelyfacilitates user interaction while in a particular mode in which deviceactivation could be problematic.

SUMMARY

Inadvertent activation of a portable medical device such as anambulatory infusion pump can be reduced by locking a touchscreen of thedevice when it is indicated that an uninterrupted operation is to beperformed. When a processor receives a device operation input from thetouchscreen that indicates an uninterrupted operation is to be performedon the portable device, the touchscreen is automatically locked suchthat touch input at the touchscreen is not processed by the processor tonavigate between or among menu screens or set pump parameters. Followingcompletion of the uninterrupted operation, the touchscreen can beunlocked. In one embodiment, the touchscreen can be unlocked byselection of an unlock icon on the touchscreen.

In an embodiment, an ambulatory infusion pump includes a housing, adelivery mechanism adapted to facilitated delivery of fluid to a userand a user interface comprising a touchscreen. A processor can beconfigured to generate menu screens for display on the touchscreen andto receive and process touch input from the touchscreen for navigationbetween or among the menu screens and for setting pump parameters. Theprocessor can further be configured to receive touch input through theuser interface that indicates an uninterrupted operation is to beperformed on the pump. In response to this touch input, the processorcan automatically locked the touch screen to prevent navigation betweenor among the menu screens or setting of pump parameters. Followingcompletion of the uninterrupted operation, the touchscreen can beunlocked.

In some embodiments, inadvertent activation is reduced by generating aplurality of menu screens for display on a touchscreen of the portabledevice. The processor can receive a device operation input from thetouchscreen that indicates an uninterrupted operation is to be performedon the portable device. The processor responds by setting a state of theportable device that is associated with the device operation input,maintaining the set state until at least a first predetermined touchinput and a second predetermined touch input that are separated in timeand each associated with a different corresponding first and secondpredetermined menu screen are received at the processor from thetouchscreen. The processor only permits navigation from the firstpredetermined menu screen to the second predetermined menu screen inresponse to the first predetermined touch input, and the processorresponds to the second predetermined touch input by changing the stateof the portable device. Limiting the user interaction in this way canincrease the device safety by permitting user interaction only in thesequence from the first predetermined menu screen to the secondpredetermined menu screen for a particular operating mode.

In an embodiment, a portable device includes a housing, a touchscreenhaving a surface on which a plurality of menu screens are displayed andfrom which touch input is received, and a processor in the housingconfigured to generate menu screens for display on the touchscreen andto receive the touch input from the touchscreen for navigation among themenu screens. The processor responds to receipt of a device operationinput that indicates an uninterrupted operation is to be performed onthe device by setting a state of the portable device that is associatedwith the device operation input and maintaining the set state until atleast a first predetermined touch input and a second predetermined touchinput that are separated in time and each associated with a differentcorresponding first and second predetermined menu screen, are receivedfrom the touchscreen. The processor only permits navigation from thefirst predetermined menu screen to the second predetermined menu screenin response to the first predetermined touch input, and the processorresponds to the second predetermined touch input by changing the stateof the portable device.

Other features and advantages of the present invention should beapparent from the following description of preferred embodiments thatillustrate, by way of example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a portable medical device including an interactive screenelement such as a touchscreen in one embodiment.

FIG. 2 is a block diagram that illustrates components of the portablemedical device of FIG. 1.

FIGS. 3A-3C are state diagrams that illustrate an exemplary load set-upsequence according to an embodiment of the present invention.

FIG. 4 is an exemplary screenshot of a home screen provided in FIG. 3A.

FIG. 5 is an exemplary screenshot of a load screen having two availableoptions for selection by the user provided in FIG. 3A.

FIG. 6 is an exemplary screenshot of a load screen having all availableoptions for selection by the user provided in FIG. 3B.

FIG. 7 is an exemplary screenshot of a confirmation screen for selectionof a state change provided in FIGS. 3A-3B.

FIG. 8 is an exemplary screenshot of a home screen showing a deliverystop state provided in FIGS. 3A-3B.

FIG. 9 is an exemplary screenshot of a notification screen in FIG. 3C.

FIG. 10 is an exemplary screenshot of a state change confirmation screenin FIG. 3C.

FIG. 11 is an exemplary screenshot of a current state notificationscreen in FIG. 3C.

FIGS. 12A-12B are state diagrams that illustrate an exemplary changecartridge sequence in an embodiment of the present invention.

FIG. 13 is an exemplary screenshot of a alert screen provided in thesequence of FIG. 12A.

FIG. 14 is an exemplary screenshot of a notification screen provided inthe sequence of FIG. 12A.

FIG. 15 is an exemplary screenshot of a state change confirmation screenprovided in the sequence of FIG. 12A.

FIG. 16 is an exemplary screenshot of a notification screen provided inthe sequence of FIG. 12B.

The drawings illustrate embodiments of the technology and are notlimiting. For clarity and ease of illustration, the drawings may not bemade to scale and, in some instances, various aspects may be shownexaggerated or enlarged to facilitate an understanding of particularembodiments.

DETAILED DESCRIPTION

Disclosed herein are embodiments directed to a portable medical devicehaving an interactive, e.g., touch, display screen that automaticallylocks when the system is in a load sequence which changes the physicalstate of the device. Referring to FIG. 1, a schematic representation ofa portable medical device 100 for delivering a quantity of fluid to abody is shown. FIG. 2 shows a block diagram of some of the components inthe portable medical device 100. In some embodiments, the portablemedical device may comprise a portable infusion device for the deliveryof insulin or other medicament, such as the infusion pump devicesdiscussed above. Exemplary ambulatory medical devices and featuresinclude those, e.g., disclosed in U.S. patent application Ser. No.13/557,163, U.S. patent application Ser. No. 12/714,299, U.S. patentapplication Ser. No. 12/538,018, U.S. Provisional Patent Application No.61/655,883, U.S. Provisional Patent Application No. 61/656,967 and U.S.Pat. No. 8,287,495. Each of the aforementioned documents is herebyincorporated herein by reference in its entirety.

The portable device 100 can include an infusion cartridge 102 having aninfusion set connector 104 for connection to a patient 105, andoptionally a glucose meter (not illustrated). The infusion cartridge 102can be functionally and interchangeably inserted into a receiving slot106 in a housing 108 of the portable infusion pump device 100. Theportable device includes a touchscreen 110 on which alphanumeric text,symbols, menu screens, data, and the like can be displayed, and fromwhich user input may be received via interaction such as by pressing theouter surface of the touchscreen. The type of output/ display may varyas may be useful for particular application, such as LCD displays, LEDdisplays, plasma displays, OLEO displays, organic LED (OLED) displays,and the like. The touchscreen 110 may be implemented with a capacitancescreen, a resistive screen, or other such display/input technology. Theportable device 100 may additionally include a keyboard or other inputdevice known in the art for data entry, which may be separate from thedisplay. The device may also include a capability to operatively couplevia a wired or wireless (e.g., infrared, electronic, optical, etc.) linkto one or more other devices, locally or via a network, such as, e.g., aportable or non-portable medical device, a control unit, externalmonitor or display, a personal laptop, tablet or mainframe computer, ormobile communication device such as a smartphone or personal digitalassistant (PDA), or the like. Such other devices may control or becontrolled by device 100 and/or may otherwise communicate for thetransfer of data between or among device 100 and other device(s) foranalysis of data (e.g., user data for physician review, devicediagnostic data for troubleshooting or repair), programming, or otheruses.

The infusion cartridge 102 can have an outlet 112 that is coupled to aninfusion tube 114 and the infusion set connector 104. The tube 114 andconnector 104 comprise an infusion circuit that delivers medicament tothe patient 105 at programmed times and in response to manuallyinitiated delivery.

The housing 108 of the infusion pump device 100 can be configured tohave any suitable shape and size. For instance, the housing 108 may besubstantially planar, or may be extended and tubular, or may be in theshape of a square, rectangle, circle, ellipse cylinder or the like. Thehousing 108 can be dimensioned so as to be comfortably associated with auser and/or hidden from view, for instance, placed within the clothingof a user or within a case or sleeve. For some embodiments, the housingof the pump device can have a width of about 2.5 inches to about 3.5inches, a height of about 1.0 inch to about 2.0 inches and a thicknessof about 0.2 inches to about 0.6 inches. The materials of the housing108 can vary as well. In some embodiments, the housing may beconstructed as a water-tight, or water-resistant plastic, metallic orcomposite housing that is glued or otherwise fastened togetherpermanently or semi-permanently.

A unique complication can occur for diabetic users in that they oftenbuild up calluses on the tips of their fingers as a result of bloodglucose testing, which may be problematic for operation ofcapacitive-based touch screen configurations. For example, calluses mayprevent or hinder the transfer of energy that the capacitive screens useto receive input. Accordingly, in certain embodiments, the touchscreenmay be a resistive-based touchscreen. The touchscreen, ortouch-sensitive display, may be configured to display menu screens orpages that allow the user to input data fields, e.g., select variableinputs, so as to allow the program to produce a suggested deliveryamount, rate, profile, and/or the like in an intuitive, manipulatableand/or graphic representation. The user can therefore interact with thescreen to shape the characteristic/form of the delivery amount, rate,and/or graphic delivery profile, e.g., by manipulating the deliveryestimate or pattern displayed on the screen to effectuate the actualdelivery. The portable infusion device may additionally include akeyboard or other device known in the art for data entry. Such dataentry may be separate from the screen and/or display.

Information provided by the portable infusion device may be presented onthe display screen as any number of objects, including one or morenumeric and/or alphanumeric values, a range, a value or range that ispresented in the form of a drop-down menu, a toggle that can be adjustedby the user, a graphical representation (e.g., icon) or an animatedgraphic, for example. In certain embodiments, the value is a range ofvalues that are presented on a screen of the display as a toggle,wherein the toggle may be adjusted upwards or downwards by the userwiping a finger over the screen to select the appropriate value range,e.g. appropriate range of amounts of medicament such as insulin to bedelivered and/or the appropriate rate, time, or interval of medicamentdelivery. In certain instances, the values presented in the range may beadjusted by the processor (illustrated in FIG. 2).

An infusion workflow, or protocol, may be at least part of a programthat is executed by the processor to display a sequence of menu pages toassist a user to at least program or control the portable infusiondevice and/or at least one operation comprising input, change, confirm,or view various information within the device. Any part of a workflow orprotocol may include any number of queries for prompting the user toenter, modify, or confirm information can be presented to the user onthe touchscreen display.

For example, a program accessible by the processer that includes aninfusion workflow or protocol may enable a user to program the portableinfusion device to deliver insulin to the user. In addition, an infusionworkflow may present the user with a number of understandable queriesenabling the user to enter, confirm, or modify information regarding thephysiological conditions of the user. For instance, the menu pages maypresent a series of queries to a user during the execution of a programand may enable a user to set various settings within the portableinfusion device (e.g., the time, date, or one or more alarms) and/orenter information about the user's present or predicted conditions(e.g., blood glucose level, physiological conditions, food to beingested, and the like). In general, the sequence of menu pages maycomprise a linear flow in that each menu page provides an icon or symbolthat initiates a next step or menu page in the workflow and alsoprovides an icon or symbol that reverses the workflow to proceed to apreceding menu page in the workflow.

In some embodiments, the user is provided with a virtual form displayedon the touch screen display for the user to complete. A virtual formenables a user to directly select and manipulate one or more parts of adisplayed virtual form, with each part generally representing a setting.In this way, a user is not required to navigate through a generallylinear workflow or protocol and/or prompted with a series of queries.Instead, the user is presented with a single page where the usercompletes the virtual form in order to initiate a programmed delivery ofinsulin, as will be discussed in greater detail below and shown by wayof example in FIGS. 3A-3C (with corresponding screenshots in FIGS. 4-11)and FIGS. 12A-12B (with corresponding screenshots in FIGS. 13-16).

Some menu page or screen representation embodiments of the menu pageworkflow enable a user to easily access and view one or more settingsand information within the portable infusion device. A single page mayinclude one or more objects simultaneously presented on the touchscreen, where an object may be any number of text, numbers, graphs,pictures, video, or combination thereof which display information to auser.

The settings and information may have been entered by a user and/orpresented by the portable infusion device, and may be one of informationregarding the amount of insulin already present in the body, e.g.,insulin on board; blood glucose level; trending glucose level; insulinsensitivity/insensitivity; glycemic index; metabolism; metabolic rate;stress level; physiological conditions, e.g., age, health, sickness,diurnal cycles, etc; measurable parameters: hormones, steroids, etc.;pharmacokinetics of the medicament, e.g., age of insulin, decay rate,etc.; food to be ingested, e.g., carbohydrates, proteins, fat; activity;use history; calendared events; environment, e.g., temperature,humidity, pressure, etc.; and the like. An object may represent anyinformation without departing from the scope herein, and may also be inthe form of a pictogram to generally intuitively represent a program,file, user, setting, status, profile, action, combination of theforegoing, or other entity or combination of entities discussed herein.

FIG. 1 shows an embodiment wherein the portable medical device 100 canbe coupled to a power source, such as a desktop or laptop computer or awall outlet, through a cable 118. The cable connector may comprise, forexample, a connector through which both data and electrical energy arereceived, such as when the device is coupled to a computing device.Examples of such combined power and data cables include a UniversalSerial Bus (USB) connection, an IEEE 1499 (FireWire) connection, a“Thunderbolt” connection, PCI Express, eSATA and Ethernet. The port maycomprise, for example, a standard USB port, a mini-USB port, a microUSEport, IEEE 1394 (i.e., FIREWIRE, registered to Apple, Inc., Cupertino,Calif.) port, or port for THUNDERBOLT (registered to Apple, Inc.,Cupertino, Calif.), PCI Express, eSATA or Ethernet. A compatibleconnector port 120 of the portable device 100 receives the opposite endof the cable 118. In a USB implementation, for example, the USB cable118 and associated connections and ports may support one or more of aUSB version 1.1, 2.0, or 3.0 data transfer speeds. With such combinedpower and data connections, data may be exchanged between the portablemedical infusion device 100 and a connected computer over the cable 118,and the portable medical device 100 may receive electrical power fromthe computer, as well.

Referring now to FIG. 2, a block diagram of the components within theportable medical device 100 of FIG. 1 is shown. The portable medicaldevice 100 of this embodiment includes the housing 108 and includes aconnector interface 20 coupled to the connector port 12 that receives acombined data/power cable, such as a standard, micro- or mini- USB cable118 (illustrated in FIG. 1). The connector interface 20 supports dataexchange and receives electrical power through the connector port 120(illustrated in FIG. 1), and controls a connector data element 21 a anda connector power element 21 b. The connector interface 20 passes datacommunications from the connector port 11 through the connector dataelement 21 a to a system bus 22, such as current updates to theprogramming of the portable medical device and/or current reminderssaved such as, for example, on a computer program associated with thedevice 100. The connector interface 20 also passes electrical power fromthe connector port 12 through the connector power element 21 b to abattery charger 29, which is coupled to a battery 28 and which rechargesthe battery capable of supporting operation of the portable medicaldevice 100.

A control processor 23 is connected to the system bus 22 and receivesthe data communications from the connector data element 20 forprocessing. The control processor 23 controls operation of the variouselements of the portable device 100 that are connected to the system bus22. The control processor operates according to program instructionsthat may be stored in the device memory 24. Program instructions mayalso be stored in processor memory of the control processor 23. Thecontrol processor also stores data from its operations in the memory 24.The control processor controls a data communications element 25 that maycomprise a receiver/transmitter for wireless RF communications, such as“WiFi” communications or “Bluetooth” communications between the portablemedical device 10 and compatible external systems and networks. Theportable infusion device may include an interface that allows a usersuch as a patient to interact with the programming of the processor todetermine an amount of fluid to be delivered, a rate of delivery, adelivery profile, and/or the like.

As shown in FIG. 2, the portable medical device may include a processor,such as a control processor. The processor functions for controlling theoverall functions of the portable infusion device. Specifically, theprocessor includes programming that functions to control the device andits components. The programming may comprise computer instructionsstored in memory or firmware components that, when executed by theprocessor, provide the processing and features described herein. Forinstance, the processor may communicate with, e.g., send signals toand/or receives signals from, and/or otherwise control one or more ofthe delivery mechanism, reservoir, estimators, output mechanisms (e.g.,display), memory, transmitter, receiver, alarm(s), speaker and clock orother features. The programming that is executed by the processor may bereferred to herein as the “program” or “programming” of the device.

Accordingly, the processor may include programming that it can executeto control the speed of translation of a pump mechanism, the release offluid from the reservoir, the data to be displayed by a display, thedata to be transmitted via the transmitter, the one or more alarms, etc.

The processor may also include programming that allows the processor toreceive signals and/or other data from an input device, receiver,various sensors (such as a sensor that may be included as a part of thedevice or used in conjunction therewith, for instance, a blood glucosemonitor and/or a blood glucose sensor, and the like) and to store thesame in a memory. The memory can be any type of memory capable ofstoring data and communicating that data to one or more other componentsof the device, such as the processor.

The memory 24 of the device 100 may be any type of memory capable ofstoring data and retrieving that data for transfer to one or more othercomponents of the device, such as the control processor 23. The memory24 may comprise one or more of a flash memory, SRAM, ROM, DRAM, RAM,EPROM, dynamic storage, and the like. For the illustrated portablemedical device 100 embodiment of FIG. 1, the memory 24 may be coupled tothe control processor 23 and may be configured to receive and storeinput data and/or store one or more template or predetermined fluiddelivery patterns. For example, the memory 24 can be configured to storeone or more personalized (e.g., user defined) delivery profiles, such asa profile based on a user's selection and/or grouping of various inputfactors; past generated delivery profiles; recommended deliveryprofiles; one or more traditional delivery profiles, e.g., square wave,dual square wave, basal and bolus rate profiles; and/or the like. Incertain embodiments, the portable infusion device is configured forreceiving user information about a user's present or predictedconditions. Such information may include the amount of insulin alreadypresent in the body, (e.g., “insulin on board”); blood glucose level;trending blood glucose level; insulin sensitivity/insensitivity;glycemic index; information about the user's metabolism (e.g.,“metabolic rate”); stress level; physiological conditions, (e.g., age,health, sickness, diurnal cycles, etc.); other measurable parameters(e.g., information related to amount/type of other hormones such assteroids, etc.); pharmacokinetics of the medicament (e.g., age ofinsulin, decay rate, etc.); information about the type and quantity offood to be or already ingested (e.g., carbohydrates, proteins, fat;activity; use history; calendared events); environment (e.g.,temperature, humidity, pressure, etc.); and the like. One or more ofthese factors may be entered into the device, for instance, by an inputdevice. In some embodiments, the memory 24 of the portable infusiondevice 10 may have a data capacity of up to or over about 10 GB, morespecifically, up to about 3 GB, even more specifically, about 1 MB toabout 200 MB. In some embodiments, the memory 24 of the device 10 may beup to about 3 GB, more specifically, up to about 500 MB, and even morespecifically, about 200 kB to about 200 MB. The processor includesprogramming configured for receiving such user input information, suchas that discussed above, parsing and collating the information togenerate an output, and presenting that output to a user, such as ondisplay. The device 100 includes an output/display component 26 such asthe touchscreen 110 illustrated in FIG. 1, for operating virtual buttonsor switches and the like, which may appear on the touchscreen.

The device 100 can comprise an insulin pump device, which therefore alsoincludes a drive/pump element 27 such as a pumping mechanism fordelivery of insulin fluid to the connecting tube 14, as described abovein connection with FIG. 1. The delivery mechanism may be any suitabletype of mechanism including the pumping mechanism. For some embodiments,the delivery mechanism may include a typical drive mechanism, such as adrive mechanism that includes a drive screw coupled to a motor. In suchan instance, the drive mechanism may be configured for being operablycoupled to a reservoir, such as a syringe based reservoir, and thehousing may be sized to include at least a portion of the drivemechanism and the reservoir. In some instances, the delivery mechanismmay include a hydraulics mechanism, pneumatic mechanism, step motor,continuous motor, or the like.

The actuator or drive mechanism may be configured for actuating orotherwise effecting the translation of a pump piston or element such asa spool or shuttlecock. The actuator may be any mechanism that iscapable of causing the translation of the spool. For instance, theactuator may include an electric coil, a ferrite member, a nitinolmember, a lever arm, corresponding magnets or electric magnets ordipoles.

As indicated above, the egress may be configured so as to communicatewith the spool translation chamber and/or spool and/or one or moreopenings therein. The egress may further be configured for opening andclosing or otherwise regulating the amount of fluid that is allowed topass there through. In this manner, the reservoir interacts with thedelivery mechanism to effectuate the delivery of a stored fluid from thereservoir, through the delivery mechanism, and out of the portableinfusion device, e.g., via an infusion set.

Referring now to FIGS. 3A-C, an exemplary sequence utilized to program auser defined profile into the memory element of the portable medicaldevice is illustrated. As described in the following paragraphs, theprogramming and modification of current profiles within the portablemedical device can be accomplished through user interactions with thetouch screen, or display element, of the device. Each user interaction,e.g., touch, can be interpreted as an input to control and or navigatethrough screens of the device, dependent on the region of the displayreceiving the interaction. In further embodiments, modifications andprogramming of the user profiles can be completed on a computing deviceand downloaded to the portable medical device, once the device iscoupled to the computing device. In other embodiments, the displayscreen of the portable medical device can further be utilized to provideconfirmation that the user wishes to download and/or allow datacommunications with a particular computing device, e.g., 15 such as whena user utilizes a computing device solely to charge the portable medicaldevice.

The user defined profile can allow the user to set alerts (e.g., sitereminders), delivery amounts, temperature delivery rates, test times,and the like. The user-defined profile can also allow the user to changethe physical state of the device, such as when a cartridge requiresreplacement, or when a tubing or cannula require filling. Modifying thephysical state of the device, also affects the active physical state ofthe portable medical device, as described in the load sequence of FIGS.3A-3C.

As shown in FIG. 3A, the user can initially be provided with a homescreen 301, displayed on the touchscreen 110 (illustrated in FIG. 1).The home screen 301 allows the user to view various current conditionsand states of the device. For example, FIG. 4 illustrates a home screen400 that provides the conditions (clockwise from top left) of an 80%battery life remaining, the time (8:00 AM), the date (May 25, 2010), theinsulin available in the cartridge (165 u), the time remaining beforethe next scheduled injection (4:19 hours), the insulin on board (IOB) inunits (1.1 u), an options button and a bolus button. The bolus buttonshows whether or not the bolus is in use, e.g., if the button ishighlighted, and the current amount of bolus being administered. Thebolus can be scheduled to be delivered at certain times of the day,e.g., mealtimes, such that the bolus button and insulin amountsautomatically appear during those times. The current state 401 of theportable medical device is indicated by a letter (“B”), which appearsproximate to the current cartridge amount (165 u). As shown in FIG. 4,the current state of the device is “B”, which is an active physicalstate, e.g., fluid is actively being pumped, having both basal deliveryand bolus delivery. Other states not shown can include a red “T”, whichindicates an active physical state that provides a temperature ratedelivery Ou/hr (zero units per hour); a red “0”, which indicates a basaldelivery rate at Ou/hr; “B”, which is an active physical state havingonly basal delivery (if bolus delivery is not indicated on bolusbutton); and an orange “T”, which indicates an active physical statethat provides an active temperature rate delivery as programmed by theuser.

As shown in FIG. 4, a bolus delivery state is indicated by the “X” 402mark on a bolus button 403, and the amount of the bolus delivery isindicated as “Standard: 10 u” also on the bolus button 403. A standardbolus delivery state is indicated in FIG. 4. If the bolus is in anextended delivery state, the bolus button 403 can indicate “Extended: 10u” along with the time of the extended delivery state, e.g., 8:00AM-10:30 AM. The bolus can also be in a correction state, “Correction: 1u” or a standard state with a correction “Standard/Correction: 10 u”. Aspreviously mentioned, if an “X” mark 402 does not appear on the bolusbutton, bolus delivery is off.

If no letter “B” 401 appears on the home screen, then the portablemedical device is in an inactive state, and no basal or bolus deliveriesare occurring. Such a state is shown in FIG. and will be describedfurther with reference to FIGS. 3A-3B in the following paragraphs. Theinactive state can be noted on the home screen on the Options button as“All Deliveries Stopped”. It should be noted that if the basal deliveryis “off”, e.g., an inactive physical state, the bolus delivery state isautomatically shown as being in an “off” state as well.

Referring to FIG. 3A, the user can navigate to the options menu byselecting the “Options” button on the home screen as shown in step 303.The user can then be provided with several options, including the optionto “Load”, which modifies the physical state of the device. Once theuser selects the Load option, in step 305, the processor of the portablemedical device performs a check to determine the state of the SiteReminder, e.g., “On” or “Off” in step 307. If the Site Reminder is not“On”, the device setup is considered to be in an incomplete state.

In step 309, if the Site Reminder is “Off”, the device then checks todetermine if a cartridge is installed/detected within the device. If acartridge is not detected, the portable medical device provides the userwith only two options in the load menu 311: 1) enter the changecartridge load sequence, or 2) enter the site reminder edit sequence (totum on and program the Site Reminder function). FIG. 5 illustrates anexemplary screenshot 500 of a device that does not detect a cartridgeand that has the Site Reminder turned off. As shown in FIG. 5, only theSite Reminder button 502 and the Change Cartridge button are availablefor selection by the user in the load menu. The user then can thenselect to change the cartridge, e.g., load a cartridge into the deviceand/or correct an erroneously loaded/detected cartridge in the device asshown in step 317. The change cartridge load sequence is described infollowing paragraphs.

Referring to FIG. 3A, in step 309, if a cartridge is detected when thestate of the Site Reminder is “Off”, the user is directed to a load menu313, which includes all load functions available for selection, andreminds the user that the Site Reminder is “Off”. Accordingly, from loadmenu 313, the user can begin any load sequence option and/or change thestate of the Site Reminder. The Site Reminder is an independent setting,and can be edited without completing any of the flows (e.g., ChangeCartridge, Fill Tubing or Fill Cannula) and/or during a pumping ornon-pumping state. However, in one embodiment, when the Site Reminder isset to an “On” position, it can be part of the Fill Cannula sequence inorder to help encourage the user to set it up.

Referring to step 307, if the site reminder is set to “On”, the user isshown a load menu 315 in which all load sequence options are availablefor selection by the user and the Site Reminder button indicates an “On”state. From the load menu 315, the user can select any option previouslydescribed along with the option to change the Site Reminder. If the userselects to change the Site Reminder as shown in step 345, the devicethen enters a workflow sequence “15-2”, show in box 347, to setup thesite reminder from the load workflow. The set up of the Site Reminderfrom the load menu is slightly different than from the Fill Cannulaworkflow sequence. If the Site Reminder is set up through the load menu315 as shown in step 345, the user is able to press a “Back” button toreturn to the load menu 315 at any time. However, if the user modifiesthe Site Reminder from the Fill Cannula workflow sequence, the “Back”button is inactive as the user cannot return to a previous state in theFill Cannula workflow sequence until the sequence is completed.Accordingly, the Site Reminder is editable through the load menu and/orthrough the Fill Cannula sequence, though slight variations occur withinthe sequence which is followed for each setup.

Referring to load menus shown in boxes 311 (sequence 317 only), 313, and315, the user can select a button to enter a load sequence, such as oneof the buttons comprising Change Cartridge 317, Fill Tubing 319, or FillCannula 321. Each of the load sequence options is illustrated in FIG. 6.As each load sequence is completed, the button, which the user canselect for each particular sequence, indicates a completed mark (checkmark) 605, 606. As shown in an exemplary screenshot 600 of FIG. 6, theChange Cartridge 601 load sequence and the Fill Tubing 602 load sequencehave each been completed. The Fill Cannula 603 has not been completed,but is available for selection because a cartridge is detected in thedevice.

Furthermore, the Site Reminder 604 option is available for set-up due toits current “Off” state 607. Once at least one load sequence option hasbeen selected and completed, the user can be provided with the option tocomplete the session in the menu by selecting the “Done” button 608 onthe interactive touchscreen.

In step 323, if the user selects any one of the aforementioned loadsequences, the processor of the device checks the pumping mechanism inorder to determine if it is in an active pumping state. If the pump isnot in an active state when a load sequence is selected, the user issent to a corresponding workflow alert state. For example, if the userchose to load a cartridge, and the device is not in an active pumpingstate, the user is sent to a change cartridge alerts workflow, as shownin box 338. Similarly, if the device is in an inactive state and theuser chose to enter a fill tubing workflow or a fill cannula workflow,the user is directed to each respective workflow as shown in boxes 340and 342, respectively. If the pump is in an active state, the activephysical state of the portable medical device should be stopped.Accordingly, the user is directed to a screen, which requires a userinput to confirm that the active operation; e.g., pumping, of theportable medical device will be stopped. The user is then asked to enter“Yes” or “No” inputs for each of the load sequences to begin as shown inboxes 327, 329 and 331. This is provided in order for the user to avoidunwanted stopping of the pump, such as when a current scheduled infusionis occurring.

FIG. 7 shows an exemplary screenshot of the confirmation screen 700 onthe display of the device for stopping the active operation. In theparticular screen 700 shown, the display notifies the user that aselection of the Change Cartridge load sequence will cause alldeliveries to be stopped. The user is given two options 701, in the formof two alternative touchscreen buttons, either to continue the ChangeCartridge load sequence with “Yes” or to exit the load sequence requestwith the “No” button. If the user selects the “No” button, the devicereturns back to the same load menu previously displayed. As shown inFIG. 3A, the selection of the “No” button is illustrated in step 325 andreturns the user to a load menu 311, 313, or 315. Alternatively, if theuser selects the “Yes” button to confirm entering the load sequence, asin step 333, the user is provided with a final confirmation screen. Thefinal confirmation screen can be an alert to the user that provides theuser with a notification that the current active physical state of thedevice has changed; e.g., all deliveries have been stopped, a providedin step 335. The final confirmation screen can remain on the screen ofthe device until the next step in the load sequence is complete, such asthe replacement of a cartridge, or until the user has acknowledged thephysical state change of the device for a second time; e.g., the firsttime being screen 700 with option 701 in FIG. 7.

Referring to FIG. 8, when the device enters the Change Cartridge loadsequence, or another load sequence in which the physical state of thedevice has changed, notification or alert reflecting the current stateof the device is also displayed on the main menu screen 800 of thedevice. Accordingly, the Bolus delivery button is unavailable and theoptions button 801 indicates that “All Deliveries Stopped” at thecurrent time. In an embodiment where the device is in a Change Cartridgeload sequence, the device then automatically stops all deliveries andbypasses prompts received when stopping individual delivery types (e.g.,bolus, basal, temperature), as shown in state 335. Dependent on the loadsequence chosen in boxes 317, 319. 321, the processor can direct thedevice to enter the particular load sequence 343, 341, 339.

Referring now to FIG. 3B, after completing one or more of the loadsequences 343, 341, 339 selected by the user in FIG. 3A, the processorof the device then determines whether the Site Reminder is in an “On” or“Off” state. If the Site Reminder is in the “Off” state, then the usercan be directed to a Load Menu that indicates one or more of the loadsequences have been completed, such as shown in the exemplary screenshotof FIG. 6. For example, box 357 can show the user that specific taskssuch as the “Change Cartridge” load sequence has been completed and/orthe “Fill Cannula” load sequence has been completed. Each completed loadsequence can have an illuminated, or highlighted, checkmark on that loadoption button.

If the Site Reminder is in the “On” state, then as shown in box 359,when all load sequences have been requested and completed by the user,the user can still be directed to the Load menu in order to configureand/or change the Site Reminder to the “On” state, since the portablemedical device is then prepared for an active physical state. If theuser has completed all load sequences and the Site Reminder is in the“On” state, the user can be provided with an option to enter an input of“Done” for the current workflow session. In some embodiments, if allload sequences, in particular the Fill Cannula load sequence, iscomplete, the Fill Cannula button is not active, or highlighted, forselection by the user though the completed checkmark is visible (e.g.,highlighted or lit). This prevents the user from requesting an overflowof the cannula.

Referring again to boxes 357 and 359, once the user has entered andcompleted a particular load sequence, the user can be provided with,e.g., three (3) options to navigate away from the current device state.For example, in order for the user to exit the Load Menu and end acurrent workflow session, the user can select the “Done” button on thetouchscreen of the device as provided in box 363. The Done button cantake the user back to the Home Screen of the device, such as shown inFIG. 4. However, as previously mentioned, the Done button is onlyavailable for selection if at least one of the load sequences has beencompleted after selection by the user, as shown in the device checkstate of 369. If the portable medical device has completed at least oneload sequence, the user is shown a screen indicating that the usershould perform “Test BG in 1-2 hours” (blood glucose) as provided in box371. This should be performed in order for the user to determine if alldevice components and physical modifications; e.g., cartridge change,cannula fill, tubing fill, were completed successfully. The user doesnot need to navigate away from the screen described in box 371, becausethe device can automatically navigate to a sequence to start an activestate of resuming insulin workflow as provided in box 373. In analternative embodiment, if no load sequence is determined as beingcompleted by the device in the check state of 369, the device canautomatically navigate to the resume active state in box 3 73. This mayoccur when the user has entered the load menu to view each availableload option and/or edit the Site Reminder settings and/or has exited aload sequence prior to completion and is exciting the current loadsession Load menu.

Referring to the Load menus 357, 359, 361, in a second option tonavigate away from any of these screens, the user can select the “Back”button. The Back button takes the user out of the current workflowsession, or a specific workflow sequence in which the device currentlyis, to the Options menu. Prior to displaying the Options menu to theuser, the system can run a similar check state of 369 discussed in theprevious paragraph, which navigates to the notification screen of “TestBG in 1-2 hours” in box 3 71 if at least one load sequence has beencompleted and then to the resume active state 3 73. Again, the devicebypasses the notification in box 3 71 if no load sequence has beencompleted by the device, and automatically enters the resume activestate workflow in box 3 73. Once in the active state and not in thelocked state, such as when the device is capable of being unlocked, theuser is free to navigate through the device to perform tasks such asselecting custom options, editing and generating profiles, and viewingstored data.

Referring now to FIG. 3C, though the user can navigate away from theLoad menu with the Back button or Done button as provided in FIG. 3B,the device performs a series of checks prior to allowing the device toresume an active state in a Menu Complete workflow sequence as shown inbox 377 of FIG. 3C. In some cases, the user is notified with an errormessage and in others the user is asked to confirm that the active statewill be resumed. In some embodiments, the only way for the portablemedical device to commence an active state is for certain conditionsassociated with the Load menu to be satisfied. The conditions arefurther explained in the following paragraphs with references tocorresponding exemplary screenshots in FIGS. 9-11.

As shown in FIG. 3C, once the Menu Complete workflow sequence has begun,the device first checks if the device is recovering from a fault statein state 378, such as a mechanical or software failure state. If thedevice is recovering from a fault state, the user can receive an errormessage indicating that the portable medical device cannot enter anactive state; e.g., the pump cannot resume pumping as shown in box 3 78a. The user is then asked to confirm that the error message has beenread in box 378 a, by selecting a “Close” button provided in box 384.This ensures that the user is aware of the fact that no insulin will bereceived from the device and other injection methods may be required.The user is then directed to an Options menu for “Resume Insulin state”provided in box 385 in order to troubleshoot the current detected error.All active operation of the device, e.g., pumping, remains in the “Off”state and no deliveries are occurring.

If the device is not recovering from a fault state, the processor thenruns a second check to determine if the date provided on the device isvalid, as provided in state 3 79. If the check fails; e.g., the date isincorrect, the user can receive an error message indicating the problemin box 379 a. The user is then asked to confirm receipt of the errormessage by selecting a “Close” button as provided in box 384. The useris then directed to the Options menu for “Resume Insulin state” providedin box 385 in order to troubleshoot the current detected error. Allactive operation of the device; e.g., pumping, remains in the “Off”state and no deliveries are occurring.

If the device has a valid date, the processor then runs a third check todetermine if the mechanical components, such as the buttons on thetouchscreen or other push buttons on the device, are malfunctioning asprovided in state 380. If a button is malfunctioning, such as by beingstuck, the user is again notified via an error message in 380 a that thedevice will not resume an active pumping state. The user is then askedto confirm receipt of the error message by selecting a “Close” button asprovided in state 384. The user is then directed to the Options menu for“Resume Insulin state” provided in box 385 in order to troubleshoot thecurrent detected error. All active operation of the device; e.g.,pumping, remains in the “Off” state and no deliveries are occurring.

Referring to FIG. 9, if the device passes the third check, and allbuttons are fully functional, the processor checks the current batterylevel within the device as in state 381. This ensures proper delivery ofthe infusion fluid, e.g., insulin, will occur at the scheduled timesdetermined by the stored user profile. If the battery level is too low,the processor provides the user with a notification 900 in the form ofan error message indicating a low battery level in box 381 a. The useris then asked to confirm receipt of the error message by selecting a“Close” button 901 as provided in box 384. The user is then directed tothe Options menu for “Resume Insulin state” provided in box 385 in orderto troubleshoot the current detected error. All active operation of thedevice; e.g., pumping, remains in the “Off” state and no deliveries areallowed to occur.

If the portable medical device has sufficient battery power to operatein an active state, the processor performs the next check to determineif any outside factors may affect the correct operation of the device.As shown in state 382, the fourth check is utilized to determine if theprocessor detects any extreme temperatures. Extreme temperatures may bethe result of outside conditions, such as extremely hot or cold outsidetemperatures. In the case of an extremely hot temperature, the user isagain provided with an error message indicating that the device detectsa high temperature provided in box 382 a, and the user is then asked toconfirm receipt of the error message by selecting a “Close” button asprovided in box 384. The user is then directed to the Options menu for“Resume Insulin state” provided in box 385 in order to troubleshoot thecurrent detected error. All active operation of the device, e.g.,pumping, remains in the “Off” state and no medicament delivery isoccurring. In some embodiments, a similar operation is provided in thecase of an extremely cold temperature.

Finally, the processor of the portable medical device performs a fifthcheck to again determine if an additional outside factor of altitude isdetected in state 383. If an abnormal altitude is detected, the devicemay not operate properly. Accordingly, if a high altitude is detected,then the user is provided a notification of high altitude being detectedsuch that an active state cannot be resumed in box 383 a. The user isthen asked to confirm receipt of the error message by selecting a“Close” button as provided in box 384.

If the processor of the device detects a suitable altitude foroperation, the Load Menu Complete workflow sequence then performsindividual checks of the physical components of the device that provideproper active operation in states 386, 387 and 388. The processor of theportable medical device first determines if the Cartridge Tubing hasbeen filled in state 386. If the tubing is not filled, the user isprovided a sequence of screens similar to the aforementioned checks.First, the user is notified in an error message in box 386 a that theCartridge Tubing must be filled to continue with active operation of theportable medical device. The user is then asked to confirm receipt ofthe error message by selecting a “Close” button as provided in box 389.The user is then directed to the Options menu for “Resume Insulin state”provided in box 390 in order to troubleshoot the current detected error.All active operation of the device, e.g., pumping, remains in the “Off”state and no deliveries are occurring.

Next, if the cartridge tubing is successfully filled as noted by thegreen check mark on the “Fill Tubing” bar 602, the processor of thedevice performs a check to determine if the cartridge has beensuccessfully loaded into the device in state 387 a. If the cartridge wasinstalled incorrectly, the user is notified in an error message that thecartridge requires reinstallation. The user is then asked to confirmreceipt of the error message by selecting a “Close” button as providedin box 389. The user is then directed to the Options menu for “ResumeInsulin state” provided in box 390 in order to troubleshoot the currentdetected error. All active operation of the device; e.g., pumping,remains in the “Off” state and no deliveries are occurring.

Referring to FIG. 10, once the device processor runs through all checkson the device and the device determines that all components arefunctional, the user is then directed to an Options screen to “ResumeInsulin Now” 1000. This is presented when the device is in a functionaloperating state and the user programmed profiles and deliveries can besafely resumed. The user is provided with two options 1001 to “Resume”or “Close” the Options screen; e.g., if the user wishes to performanother load sequence.

Referring to FIG. 11, if the user selects to “Resume” the active stateof the device, the device can indicate to the user that the device is“Resuming Insulin” deliveries as shown in screenshot 1100. In someembodiments, the “Resuming Insulin” screen 1100 can remain on the deviceuntil a first insulin delivery has been made. In other embodiments, the“Resuming Insulin” screen 1100 can remain on the screen of the devicefor a predetermined time period, such as 10 seconds.

In the previously described Load Menu Complete workflow sequence, itshould be understood that all or some of the checks performed on thedevice can be sequentially or simultaneously performed. Additionally, atany step within the Load Menu Complete workflow sequence, similar to anystep navigating through the device from the Home screen to the OptionMenu and, subsequently, to the Load Menu, the user is provided with atleast two options to navigate away from current screen by selecting a“Yes”, “No”, “Continue”, “Back” or “Close” button. The “Close” buttonallows the device to remain in a hold state in order for a notificationmessage to be confirmed by the user. However, after acceptance, e.g.,interaction with the screen on the “Close” button, the user is directedto a following screen which offers two or more options for the user tonavigate through functions of the device; e.g., the load sequenceoptions on the Load menu.

Referring now to FIGS. 12A-12B, a load sequence workflow for changing acartridge on the device is described with further reference to FIGS.13-16.

As shown in FIG. 12A, the change cartridge load sequence, which can beinitialized through the Load menu described in FIGS. 3A-3C, begins witha device check process in state 120 to determine if a cartridge iscurrently installed and/or installed correctly in the device. If nocartridge and/or a erroneously installed cartridge is detected by theprocessor, the user is directed to an notification screen including analert that indicates an error with the cartridge provided in box 128. Anexemplary screenshot of box 128 is shown in FIG. 13. As previouslydiscussed, once the user enters the load sequence for changing acartridge, either inadvertently (e.g., incorrect removal/installation ofcartridge at box 128) or intentionally (e.g., navigation through loadmenu at box 126), all deliveries and active operation of the device arestopped.

Referring again to FIG. 12A, if the user is shown the notification instate 128, two options are provided to navigate away from thenotification screen, “Yes” and “No”. These two options 1301 are alsoshown in the exemplary notification, or alert screenshot 1300 of FIG.13. If the user selects “No” shown in box 136, the processor of thedevice directs the user to begin a load sequence for reconnecting theincorrectly installed cartridge of the device as shown in box 138. Ifthe user selects that a cartridge is currently being installed, “Yes” inbox 134, the user can then be directed by the processor to thepredefined Change Cartridge load sequence screens. The screens areprovided in order to guide the user through the cartridge changingprocess with simple instructions and failsafe mechanisms to ensure thatproper device functions occur.

In particular, the Change Cartridge load sequence, along with the FillTubing and Fill Cannula load sequences, includes a failsafe mechanismthat locks the screen of the device during a physical modification(e.g., removal/installation of cartridge, filling of cannula, etc.) suchthat any inadvertent interaction with the screen of the device isavoided. Accordingly, though the device is still functional; e.g.,background processing is occurring, the current state of the devicecannot be modified until the screen is unlocked. For example, if theuser touches the screen of the device while removing the cartridge orfilling the tubing, the screen will not input the touch that causes thedevice 1301 to move away from the current screen in the workflow processand begin, for example, the delivery of the insulin to the tube whendisconnected from the patient on accident.

As provided in FIG. 12A, when the device is instructed to enter thechange cartridge load sequence in box 126 in response to a user input,the user is notified on the device screen when it is safe to remove theinfusion from his/her body in box 130. The user is also instructed tothe remove the cartridge from the device and is informed that the devicescreen is currently in a locked state. As shown in box 130, anadditional icon appears on the user's device screen, indicating that thescreen of the device is locked; e.g., a padlock icon. This icon and box130 are provided in an exemplary screenshot 1400 in FIG. 14. The icon1402 covers a small region of the display screen and, when active,indicates that any other surface of display screen is not capable ofreceiving an input, e.g., through a physical interaction with thedevice. The indication that the screen is in a locked state 1401 is alsoshown, but is not active, e.g., highlighted, as this region is notcurrently able to receive an input. Accordingly, in order to for theuser to view the next screen in the cartridge change load sequence, theuser is provided with only one option to provide a single (1) predefinedinput. The user can then touch the screen on the lock icon 1402 afterwhich the user is directed to a second predefined screen that ensuresthe user has completed the task at hand and confirms that the user isprepared to move forward in the current load sequence.

Referring again to FIG. 12A, when the user has selected to unlock thefirst locked screen state in box 130 (e.g., through selection of thelock button 1402 in FIG. 14), the user is provided with a subsequentscreen to confirm that he/she would like to continue through the currentload sequence, such as the Change Cartridge load sequence provided inbox 132. It is important to note that the screen provided in the screensequence immediately following the user's first request to unlock thescreen of the device is the screen described in box 132. The user isunable to navigate from a first locked screen state that appears duringa physical state change of the device to any other screen except thesubsequent confirmation screen provided in box 132. An exemplary screenshot of box 132 is illustrated in FIG. 15. As shown in FIG. 15, the onlytwo options the user has to navigate away from the screen is throughselection of “Next” or “Close” to continue with the selected loadsequence. If the user selects “Close”, the load sequence is discontinuedand the user is directed back to the Load Menu. At such a point in thesequence, the device should not include a cartridge and, thus, the userwill be only provided the “Change Cartridge” and “Set Reminder” optionsin the Load Menu. The screen will no longer be in a locked state once itdisplays the Load Menu. Accordingly, the user will be able to navigatethrough device.

If the user enters “Next” in box 132 of FIG. 12A, the user is directedto a notification screen in the load sequence, indicating the operationin progress on the device. For example, as provided in box 142, the useris notified that the device is preparing for a cartridge to beinstalled. At this point, the screen is still in a locked state and nouser input which may change the active state of the device is permitted.Only specified regions of the screen will accept an input from the useron screens which the device has predefined as input regions allowingthat user to move in a particular load sequence and/or exit the loadsequence to return to the Load Menu. For example, the screen describedin box 142 does not include any input regions on the screen which mayallow the user to navigate to another screen. Additionally, the screenis in a locked state. Accordingly, the device can receive no input untilthe specified operation completes within the device.

Referring still to FIG. 12A, once the device has completed preparing thecartridge, as described in box 142, the user is shown a screenindicating the next step in the load sequence which is to be performed.In box 144, the user is instructed to install a new cartridge in theportable device. In some embodiments, the user is provided with a visualgraphic to facilitate such physical operation. In box 144, the user canalso be notified and reminded that the screen is currently in a lockstate, and no other state changes can occur in the device. Furthermore,the user can be provided with instruction to touch, or press, the unlockbutton to move forward through the selected load sequence. Again,similar to the sequence described previously, because a physical statechange has just occurred on the device (e.g., a cartridge is installed),the user is directed to a confirmation screen which allows the user tocontinue through the load sequence or exit to the load menu in box 148.

Referring to FIG. 15, the user can again be requested to enter one oftwo options: “Close” or “Next” display buttons 1501, shown in theexemplary confirmation screenshot 1500 in FIG. 15. In some embodiments,the confirmation screen 1500 can also include a visual graphic for theuser to see how the current physical state of the device should appear.If the user selects “Close” the device exits the current load sequenceand returns to the Load Menu. At the Load menu, if the user selects“Next”, the processor of the device executes a check to detect if thecartridge preparing time has exceeded a threshold value such as, forexample, 30 seconds. If the cartridge was installed incorrectly orcannot be recognized by the device, the user is provided with an errormessage indicating that the cartridge installed cannot be utilized bythe device and should be removed and replaced, as provided in box 154.The user is provided with one option to “Close” the current screendisplaying the error message in box 156, as the load sequence cannotcontinue with a problematic cartridge. Once the user selects to closethe screen in box 156, the user is then directed to the Load Menu in box158.

Referring now to FIG. 12B, if the user correctly installed the cartridgein the load sequence described in FIG. 12A, and the processor of thedevice has recognized and prepared the cartridge for use, the user isshown a series of screens indicating the current operation in progress.For example, the user can be shown a series of screens which areutilized while the device completes certain steps of the load sequenceoperation such as “Please Wait”, shown when the device begins thecartridge detection process, “Detecting Cartridge”, shown when thedevice is detecting the cartridge, “Removing Air from Cartridge”, shownwhen the device is removing air from the cartridge, and “Preparing for aFill”, shown when the device is ready for the next step in the loadsequence.

FIG. 16 provides an exemplary screenshot 1600 of the screens notifyingthe user of the current progress of the step in the load sequence. Asshown, the user is notified that the device is currently operating toremove air from the cartridge, “Removing Air From Cartridge,” and aprogress bar 1601 indicates that the installation process is 80 percent(%) complete. The progress bar can be included in each of theaforementioned screens indicating the current progress of the operationsbeing performed in the load sequence. It should be noted that though no“lock” icon is displayed on the screen during the operation in progressscreen series just described, the screen is still in a locked state andno user inputs are capable of being received by the device.

Referring again to FIG. 12B, once the cartridge is installed and thedetection and air removal processes have been performed by the processorto prepare the cartridge for use, the processor can execute a check todetermine if any errors occurred during the cartridge detection processas shown in state 1 7 0. If an error occurred, the user can be shown anerror message alerting the user that a cartridge error has occurred inbox 172. If no errors occurred during installation and detection; e.g.,the processor of the device detects the cartridge and the air isproperly removed, the load sequence can continue to the next step. Asprovided in box 176, describing the next step in the change cartridgeload sequence, the user is provided with the next set of instructions tofill the cartridge; e.g., with insulin, and then touch the “Unlock”(press the Lock icon) when done. The user can also be reminded of thecurrent locked screen state, as depicted in a previous embodiment andshown in exemplary screenshot FIG. 14 in element 1401.

Once the user completes the load sequence step of filling the cartridgeand selecting the “Unlock” button, the processor only allows the user tonavigate to the next confirmation screen with selection of the unlockbutton after a physical state change has occurred on the device. Theconfirmation screen provided in box 180 is similar to those previouslydescribed in boxes 132 and 148 of FIG. 12A. The user is provided withtwo options to continue in the load sequence, “Close” or “Next”. If theuser selects “Close”, the user is directed to the Load Menu. If the userselects “Next”, the user is shown a notification message indicating thecartridge was successfully changed as provided in box 184. After thenotification message is displayed for a predetermined amount of timesufficient for user viewing, the processor of the device directs theuser to the next load sequence, such as, for example, the Fill Tubingworkflow provided in box 186.

As previously described with reference to boxes 132 and 148 of FIG. 12A,and box 180 of FIG. 12B, if the user selects to “Close” the currentworkflow, or load sequence, the user is directed back to the Load Menu.Though transparent to the user, the processor determines that thecurrent workflow is incomplete and runs a series of checks when such aselection is made in order to determine the current physical state ofthe device and to determine which operations need to occur in order forthe device to function properly. Accordingly, each time the user selectsto prematurely close out of the workflow sequence, the device runsthrough the checks, for example, previously described with reference toFIG. 3C.

In further embodiments, the user can enter the Fill Tubing workflow, orLoad Sequence from the Load Menu. Further details of such operationswill be apparent to those skilled in the art, in view of the descriptionin this document.

Although the aforementioned description specifically describes aportable medical device for administering insulin to a patient, itshould be understood that such a device is only one embodiment of theinvention. The device can also include any portable device having adisplay and a processor and which is capable of remaining in a specificresponse state while the another operation is being performed on thedevice. For example, the device can include a mobile computing device,such as a Smartphone. In one embodiment, such a device can be used toremotely control a portable medical device as described herein.Alternatively, a portable medical device as described herein may becontrolled by a dedicated remote control specifically designed for usewith the device. The response state can be preventing any user inputwhile a user is downloading an application through a wirelessconnection, or completing a bank transaction, for example.

The methods, systems, and devices discussed above are intended merely tobe examples. Various embodiments may omit, substitute, or add variousprocedures or components as appropriate. For example, it should beappreciated that, in alternative embodiments, the methods may beperformed in an order different from that described, and various stepsmay be added, omitted, or combined. Also, features described withrespect to certain embodiments may be combined in various otherembodiments. Different aspects and elements of the embodiments may becombined in a similar manner. Also, it should be emphasized thattechnology evolves and, thus, many of the elements are examples andshould not be interpreted to limit the scope of the invention.

Specific details are given in this description to provide a thoroughunderstanding of the embodiments. Nevertheless, it will be understood byone of ordinary skill in the art that the embodiments may be practicedwithout these specific details. For example, well-known circuits,processes, algorithms, structures, and techniques have been shownwithout unnecessary detail in order to avoid obscuring the embodiments.Further, the headings provided herein are intended merely to aid in theclarity of the descriptions of various embodiments, and should not beconstrued as limiting the scope of the invention or the functionality ofany part of the invention. For example, certain methods or componentsmay be implemented as part of other methods or components, even thoughthey are described under different headings.

It is noted that embodiments may have been described as a process thatis depicted as a flow diagram or block diagram. Although each diagrammay describe the process as a sequential series of operations, many ofthe operations can be performed in parallel or concurrently. Inaddition, the order of the operations may be rearranged. A process mayhave additional steps not included in the figures. Each operation of aprocess is performed or executed by the processor of the device.

The description above has been provided in terms of presently preferredembodiments so that an understanding of the present invention can beconveyed. There are, however, many configurations and techniques fordata management systems that were not specifically described herein, butwith which the present invention is applicable. The present inventionshould therefore not be seen as limited to the particular embodimentsdescribed herein, but rather, it should be understood that the presentinvention has wide applicability with respect to data managementgenerally. All modifications, variations, or equivalent arrangements andimplementations that are within the scope of the attached claims shouldtherefore be considered within the scope of the invention.

1. An ambulatory infusion pump, comprising: a housing; a deliverymechanism at least partially contained within the housing and adapted tofacilitate delivery of fluid to a user; a user interface comprising atouchscreen disposed on a surface of the housing; and a processordisposed in the housing and configured to generate menu screens fordisplay on the touchscreen and to receive and process touch input fromthe touchscreen for navigation between or among the menu screens and forsetting pump parameters, the processor further configured to: receivetouch input through the user interface indicating that an uninterruptedoperation is to be performed on the pump; automatically lock thetouchscreen during the uninterrupted operation in response to the touchinput such that touch input received at the touchscreen is not processedby the processor to navigate between or among menu screens or set pumpparameters; and unlock the touchscreen following completion of theuninterrupted operation.
 2. The ambulatory infusion pump of claim 1,wherein the processor is configured to unlock the touchscreen followingcompletion of the uninterrupted operation only upon receiving apredefined unlock touch input through the touchscreen.
 3. The ambulatoryinfusion pump of claim 2, wherein the predefined unlock touch input isselection of an unlock icon.
 4. The ambulatory infusion pump of claim 1,further comprising an infusion cartridge selectively coupleable to thehousing, the infusion cartridge including a reservoir containing thefluid and an outlet adapted to be coupled to infusion tubing such thatthe delivery mechanism can deliver fluid from the reservoir, out theoutlet and through the infusion tubing to a user.
 5. The ambulatoryinfusion pump of claim 4, wherein the uninterrupted operation isreplacement of the infusion cartridge.
 6. The ambulatory infusion pumpof claim 4, wherein the uninterrupted operation includes filling theinfusion cartridge with fluid.
 7. The ambulatory infusion pump of claim4, wherein the uninterrupted operation includes filling the infusiontubing with fluid.
 8. The ambulatory infusion pump of claim 2, whereinfollowing receipt of the predefined unlock touch input through thetouchscreen, the processor is adapted to display an unlock confirmationscreen and the processor does not navigate to a subsequent menu screenuntil a confirmation touch input is received on the unlock confirmationscreen.
 9. An ambulatory infusion system, comprising: an infusioncartridge, the infusion cartridge including a reservoir for containing afluid and an outlet adapted to be coupled to infusion tubing; a pumpdevice configured to selectively receive the infusion cartridge andcooperate with the infusion cartridge to deliver fluid from thereservoir, out the outlet and through infusion tubing to a user; a userinterface comprising a touchscreen disposed on a surface of the pumpdevice; and a processor located in one of the infusion cartridge and thepump and configured to generate menu screens for display on thetouchscreen and to receive and process touch input from the touchscreenfor navigation between or among the menu screens and for setting pumpparameters, the processor further configured to: receive touch inputthrough the user interface indicating that an uninterrupted operation isto be performed on the pump; automatically lock the touchscreen duringthe uninterrupted operation in response to the touch input such thattouch input received at the touchscreen is not processed by theprocessor to navigate between or among menu screens or set pumpparameters; and unlock the touchscreen following completion of theuninterrupted operation.
 10. The ambulatory infusion system of claim 9,wherein the processor is configured to unlock the touchscreen followingcompletion of the uninterrupted operation only upon receiving apredefined unlock touch input through the touchscreen.
 11. Theambulatory infusion system of claim 10, wherein the predefined unlocktouch input is selection of an unlock icon.
 12. The ambulatory infusionsystem of claim 10, wherein the uninterrupted operation is replacementof the infusion cartridge.
 13. The ambulatory infusion system of claim10, wherein the uninterrupted operation includes filling the infusioncartridge with fluid.
 14. The ambulatory infusion system of claim 10,wherein the uninterrupted operation includes filling the infusion tubingwith fluid.
 15. The ambulatory infusion system of claim 11, whereinfollowing receipt of the predefined unlock touch input through thetouchscreen, the processor is adapted to display an unlock confirmationscreen and the processor does not navigate to a subsequent menu screenuntil a confirmation touch input is received on the unlock confirmationscreen.